The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis

NCT ID: NCT02655640

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-03-31

Brief Summary

This research project has the overall objective to investigate the direction of the associations between illness perceptions, their influencing factors and health-related outcomes. Moreover, the investigators want to look at the direction of the associations between illness perceptions and health related outcomes such as psychological and physical functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc). The investigators want to know whether the outcome variables anxiety, depression, physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients' illness perceptions but also the illness perceptions of the General Practitioners (GP) and rheumatologists will be investigated. The researchers want to know if the doctors' perceptions have an impact on the physical and psychological functioning of the patient or vice versa. Much research in the field of illness perceptions is cross-sectional in nature which means that the direction of the relationships between variables is not known.

Detailed Description

This is a single center academic study at two timepoints with an interval of 12 months. The data collection includes demographic variables, patient-reported variables, clinical variables and healthcare professionals-reported variables. All SSc and SLE patients who meet the inclusion criteria and are monitored by the rheumatology consultation in the University Hospitals Leuven will be contacted to participate in the study. Patients will be informed of the purpose of the study and what is expected of them. If they agree to participate they will also be asked to sign the Informed Consent form to send together with the completed questionnaire by mail.

After the patient gives his/her agreement to participate his/ her GP and rheumatologist will be asked to fill out the Revised Illness Perception Questionnaire for Healthcare Professionals (IPQ-R HP). This is a questionnaire that measures the perception of the doctor about the disease condition of their patient.

Data will be collected and kept by the investigator for analysis after complete coding. The obtained data will be analyzed using statistical methods.

With this study the investigators want to give an answer on 4 research questions:

1. Are there differences in perceptions between GP's and rheumatologists?

2. What is the direction of the associations between the illness perceptions of the physicians and patients?

3. What is the direction of the associations between the illness perceptions of a patient with SLE or SSc and psychological and physical functioning?

4. What is the direction of the associations between the illness perceptions of the physician and the psychological and physical functioning of the patient?

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lupus

Characteristics of patients with Systemic Lupus Erythematosus. No interventions will be administered. Patients will be asked to complete questionnaires.

Questionnaires

Intervention Type: OTHER

Questionnaires will be provided to patients

Scleroderma

Characteristics of patients with Systemic Sclerosis. No interventions will be administered. Patients will be asked to complete questionnaires.

Questionnaires

Intervention Type: OTHER

Questionnaires will be provided to patients

Interventions

Questionnaires

Questionnaires will be provided to patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Before participation the patient gives informed consent.
• The medical condition of the patient allows him/her to complete a questionnaire
• The patient does not have a severe psychiatric comorbidity
• The patient can complete questionnaires in Dutch

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rene Westhovens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

References

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Reference Type: BACKGROUND

PMID: 17278916 (View on PubMed)

2. Broadbent E. Illness perceptions and health: innovations and clinical applications. Soc Personal Psychol Compass 2010, 4(4):256-266.

Reference Type: BACKGROUND

Leventhal, H, Meyer D, Nerenz D. The common-sense representation of illness danger. In S. Rachman (Ed.), Medical psychology 1980, Vol. 2: pp. 7-30. New York: Pergamon.

Reference Type: BACKGROUND

Lau RR, Bernard TM, Hartman KA. Further explorations of common-sense representations of common illnesses. Health Psychol. 1989;8(2):195-219. doi: 10.1037//0278-6133.8.2.195.

Reference Type: BACKGROUND

PMID: 2737174 (View on PubMed)

Moss-Morris R, Weinman J, Petrie KJ, Horne R, Cameron LD, Buick D. The Revised Illness Perception Questionnaire (IPQ-R). Psychol Health 2002, 17(1):1-16.

Reference Type: BACKGROUND

Benyamini, Y. Health and illness perceptions. In H. Friedman (Ed.), The oxford handbook of health psychology 2011, pp. 281-314. New York: Oxford University Press.

Reference Type: BACKGROUND

Petrie KJ, Weinman J. Patients' perception of their illness: the dynamo of volition in health care. Curr Dir Psychol Sci 2012, 21(1):60-65

Reference Type: BACKGROUND

Arat S, Verschueren P, De Langhe E, Smith V, Vanthuyne M, Diya L, Van den Heede K, Blockmans D, De Keyser F, Houssiau FA, Westhovens R. The association of illness perceptions with physical and mental health in systemic sclerosis patients: an exploratory study. Musculoskeletal Care. 2012 Mar;10(1):18-28. doi: 10.1002/msc.223. Epub 2011 Nov 11.

Reference Type: BACKGROUND

PMID: 22076953 (View on PubMed)

Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. Intentional and unintentional treatment nonadherence in patients with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2011 Mar;63(3):342-50. doi: 10.1002/acr.20411. Epub 2010 Nov 30.

Reference Type: BACKGROUND

PMID: 21120967 (View on PubMed)

Daleboudt GM, Broadbent E, McQueen F, Kaptein AA. The impact of illness perceptions on sexual functioning in patients with systemic lupus erythematosus. J Psychosom Res. 2013 Mar;74(3):260-4. doi: 10.1016/j.jpsychores.2012.11.004. Epub 2012 Nov 21.

Reference Type: BACKGROUND

PMID: 23438719 (View on PubMed)

Arat S, Rassart J, Moons P, Luyckx K, Vandenberghe J, Westhovens R. Prospective associations between illness perceptions and health outcomes in patients with systemic sclerosis and systemic lupus erythematosus: a cross-lagged analysis. Rheumatol Adv Pract. 2018 Mar 6;2(1):rky007. doi: 10.1093/rap/rky007. eCollection 2018.

Reference Type: DERIVED

PMID: 31431956 (View on PubMed)

Arat S, Lenaerts JL, De Langhe E, Verschueren P, Moons P, Vandenberghe J, Taelman V, Westhovens R. Illness representations of systemic lupus erythematosus and systemic sclerosis: a comparison of patients, their rheumatologists and their general practitioners. Lupus Sci Med. 2017 Nov 14;4(1):e000232. doi: 10.1136/lupus-2017-000232. eCollection 2017.

Reference Type: DERIVED

PMID: 29177061 (View on PubMed)

Other Identifiers

S58458

Identifier Type: -

Identifier Source: org_study_id